CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
400 µg Brimonidine Tartrate Implant +1 moredrug
Likely dose
400 µg Brimonidine Tartrate Implantfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01229410
NCT01229410Phase 1Completed

Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy

Allergan·interventional·Posted Oct 27, 2010·Updated Aug 5, 2013

In Brief

A Phase 1 clinical trial evaluating 400 µg Brimonidine Tartrate Implant and 200 µg Brimonidine Tartrate Implant for Vitrectomy. Completed, enrolled 24 participants across 2 sites in 2 countries.

Detailed Summary

This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVitrectomy
CountriesCzechia, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 27, 2010
Enrollment StartDec 1, 2010
Primary CompletionMay 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.7 years ago

Interventions

400 µg Brimonidine Tartrate Implantdrug

400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).

200 µg Brimonidine Tartrate Implantdrug

200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).